Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer

NCT01554397 | Completed Phase 2 Results DMC

• 2 other identifiers: INTERTECCR21CA162718-01
• Study Type: interventional
• Target: 101
• Locations: 6 countries
• Sites: 7

Brief Summary

The purpose of this study is to find out whether patients with cervical cancer treated with PET-guided Bone Marrow Sparing IMRT have less side effects with equal cancer control compared to standard radiation techniques (IMRT). The hypothesis is that PET-guided Bone Marrow Sparing IMRT will reduce acute hematologic and gastrointestinal toxicity and increase chemotherapy tolerance for cervical cancer patients treated with concurrent cisplatin.

Conditions

Cervical Cancer

Keywords

Cervical; Carcinoma; Cisplatin; IMRT; Radiation; INTERTECC; International; External Beam; Brachytherapy; LDR; HDR; IGRT; CBCT

Outcome Measures

Primary Outcomes (1)

• Primary Event (Acute Hematologic or GI Toxicity)

  Acute grade \>= 3 neutropenia or clinically significant \>=2 diarrhea or any grade \>=3 GI toxicity

  Up to 30 days post radiation, about one month

Secondary Outcomes (2)

• Progression-free Survival

  Up to 36 Months post treatment, a total of about 38 months

• Acute Adverse Events

  Up to 30 days post-treatment, about one month

Study Arms (2)

IMRT with concurrent cisplatin 40 mg/m2

ACTIVE COMPARATOR

Intensity-modulated Radiation Therapy (IMRT) with concurrent cisplatin 40 mg/m2

Drug: Cisplatin; Radiation: IMRT

PET-guided Bone Marrow-Sparing IMRT

EXPERIMENTAL

PET-guided Bone Marrow-Sparing IMRT with concurrent cisplatin 40 mg/m2

Radiation: PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin

Interventions

PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT) RADIATION

IMRT 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks with PET-guided Bone Marrow-Sparing

Also known as: PET-guided Bone Marrow-Sparing IMRT

PET-guided Bone Marrow-Sparing IMRT

Cisplatin DRUG

Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks

Also known as: Platinol

IMRT with concurrent cisplatin 40 mg/m2; PET-guided Bone Marrow-Sparing IMRT

IMRT RADIATION

IMRT 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks

Also known as: Intensity Modulated Radiation Therapy

IMRT with concurrent cisplatin 40 mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
• Biopsy result positive for carcinoma within 60 days prior to registration
• FIGO clinical stage I-IVA disease, based on standard diagnostic workup, including:History/physical examination and/or Examination under anesthesia (if indicated)
• If the patient is status post hysterectomy, one or more of the following conditions must be present: positive lymph nodes, positive margins, parametrial invasion, or non-radical surgery (i.e., simple hysterectomy).
• If the patient is inoperable, one or more of the following conditions must be present: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozen section, and/or parametrial invasion
• Within 42 days prior to registration, the patient must have any of the following, if clinically indicated: examination under anesthesia, cystoscopy, sigmoidoscopy, rigid proctoscopy, or colonoscopy.
• X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior to registration;
• CT scan, MRI, or PET/CT of the pelvis within 42 days prior to registration;
• Karnofsky Performance Status 60-100
• Absolute neutrophil count (ANC) ≥ 1500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable); Creatinine clearance ≥ 50 mg/dl; Bilirubin \< 1.5 mg/dl; WBC ≥ 3,000/μl; ALT/AST \< 3 x ULN; INR ≤ 1.5
• Negative serum pregnancy test for women of child-bearing potential

You may not qualify if:

• Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years;
• Prior systemic chemotherapy within the past three years
• Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation therapy fields;
• Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvic nodal metastasis is defined as either: Radiographic evidence of nodal metastasis on CT or MRI (node having short axis diameter \> 1 cm)OR Radiographic evidence of nodal metastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake as determined and documented by the radiologist)OR Biopsy-proven metastasis (e.g. needle biopsy) in undissected node
• Distant metastasis
• Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any of the patient's physicians requires an immediate change in management;
• Uncompensated heart disease or uncontrolled high blood pressure
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition

Sponsors & Collaborators

• University of California, San Diego: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Moores UC San Diego Cancer Center

La Jolla, California, 92093, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Xijing Hospital

Xi'an, 710032, China

Location

University Hospital Hradec Králové

Hradec Králové, Czechia

Location

Tata Memorial Hospital

Pārel, Mumbai, 400 012, India

Location

Marie Sklodowska Cancer Center

Gliwice, Poland

Location

King Chulalongkorn Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Carcinoma

Interventions

Cisplatin; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. Loren Mell
• Organization: UCSD Moores Cancer Center

lmell@health.ucsd.edu

858-246-4071

Study Officials

• Loren Mell, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director Division of Clinical and Translational Research, Department of Radiation Medicine and Applied Sciences.

Model Details: Phase II: IMRT (standard) vs. PET-guided Bone Marrow-Sparing IMRT (experimental), non-randomized Phase III: IMRT (standard) vs. PET-guided Bone Marrow-Sparing IMRT (experimental), randomized

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 15, 2012
• Study Start: October 13, 2011
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Locations

IN (1); CN (1); US (2); TH (1); CZ (1); PL (1)