NCT00331760|CompletedPhase 2ResultsDMC

Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery

A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma

Radiation Therapy Oncology Group ClinicalTrials.gov

Compare

2 other identifiers

RTOG-0418CDR0000472905

Study Type

interventional

Target

106

Locations

2 countries

Sites

153

Timeline

RegisteredMay 2006

StartedMar 2006

CompletionDec 2016

Brief Summary

RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

106

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Mar 2006

Longer than P75 for phase_2

Geographic Reach

2 countries

153 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.8 years study duration

Study Start

First participant enrolled

March 1, 2006

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

4.3 years until next milestone

Results Posted

Study results publicly available

June 3, 2013

Completed

3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

May 30, 2006

Results QC Date

April 12, 2013

Last Update Submit

February 1, 2019

Conditions

Cervical Cancer Endometrial Cancer

Keywords

stage I endometrial carcinomastage II endometrial carcinomastage III endometrial carcinomaendometrial adenoacanthomaendometrial adenocarcinomaendometrial adenosquamous cell carcinomastage IB cervical cancerstage IIA cervical cancerstage IIB cervical cancercervical adenocarcinomacervical adenosquamous cell carcinomacervical squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is \<= 80%. The alternative hypothesis is that the true probability is \>= 95%. For \[vagina / pelvic lymph nodes\]: UD is defined as: The 90% isodose surface covers \< 95% of \[internal target volume (ITV)/ planned target volume (PTV)\] 50.4 or \> 5% of the \[ITV/PTV\] 50.4 receives over 115%.
IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.

Secondary Outcomes (8)

Percentage of Patients With Grade 2+ Bowel Adverse Events
From the start of treatment to 90 days.
Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events
From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant
From start to end of chemotherapy, approximately five weeks from registration.
Rate of Local-regional Failure at Five Years
From registration to five years.
+3 more secondary outcomes

Study Arms (2)

Endometrial Cancer: IMRT

OTHER

Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.

Radiation: intensity-modulated radiation therapy

Cervical Cancer: IMRT + Chemotherapy (cisplatin)

OTHER

Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks and concurrent weekly cisplatin 40 mg/m\^2 for five weeks.

Drug: cisplatinRadiation: intensity-modulated radiation therapy

Interventions

cisplatinDRUG

Cervical Cancer: IMRT + Chemotherapy (cisplatin)

intensity-modulated radiation therapyRADIATION

Cervical Cancer: IMRT + Chemotherapy (cisplatin)Endometrial Cancer: IMRT

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry * Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy * Histologically confirmed diagnosis of 1 of the following: * Endometrial cancer meeting 1 of the following criteria: * Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy * Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease * Stage IIIC with all of the following: * Pelvic lymph node positive only * Para-aortic nodes sampled negative * Not receiving chemotherapy * Cervical cancer meeting 1 of the following criteria: * Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following: * Positive pelvic nodes (negative para-aortic nodes) * Microscopic parametrial involvement and negative margins * Disease qualified by Sedlis criteria must have 2 of the following risk factors: * 1/3 or more stromal invasion * Lymph-vascular space invasion * Large clinical tumor diameter (≥ 4 cm) * Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan * No requirement for extended-field radiotherapy beyond the pelvis * No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor * No evidence of metastatic disease outside of the pelvis * No microscopic involvement of the resection margin (\< 3 mm) PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only) * Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only) * Platelet count ≥ 100,000/mm³ (cervical cancer patients only) * Hemoglobin ≥ 8.0 g/dL (transfusion allowed) * Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only) * Creatinine clearance ≥ 50 mL/min (cervical cancer patients only) * AST (aspartate aminotransferase) ≤ 2 times upper limit of normal * Bilirubin ≤ 2 times upper limit of normal * Patients must not exceed the weight and size limits of the treatment table or CT scanner * No mental status changes or bladder control problems that would preclude study compliance with bladder-filling instructions * No active inflammatory bowel disease * No severe, active, concurrent illness, defined as any of the following: * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * Transmural myocardial infarction within the past 6 months * Acute bacterial or fungal infection requiring IV antibiotics * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * AIDS * No history of allergy to cisplatin (cervical cancer patients) * No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields * No prior platinum-based chemotherapy (cervical cancer patients) * No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or pegfilgrastim) * No concurrent prophylactic thrombopoietic agents * No concurrent amifostine or other protective agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Radiation Therapy Oncology Grouplead
National Cancer Institute (NCI)collaborator
NRG Oncologycollaborator

Study Sites (153)

Auburn Radiation Oncology

Auburn, California, 95603, United States

Location

Radiation Oncology Centers - Cameron Park

Cameron Park, California, 95682, United States

Location

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Eden Medical Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus