Proton Beam Radiation Therapy and Cisplatin in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer and Positive Lymph Nodes

NCT01019278 | Withdrawn Phase 2 DMC

• 2 other identifiers: UPCC 22808NCI-2009-01350
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Specialized radiation therapy, such as proton beam radiotherapy, 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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving proton beam radiation therapy together with cisplatin works in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer and positive lymph nodes.

Conditions

Cervical Cancer; Stage IB Cervical Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage IVA Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility

• Acute toxicity, as assessed by NCI CTC Version 4.0

  Within 60-90 days following completion of proton therapy

Secondary Outcomes (2)

• Late toxicity, as assessed by RTOG/EORTC late morbidity scoring system

  More than 90 days after starting therapy

• Clinical efficacy (time to local failure, time to distant failure, overall survival)

Study Arms (1)

Arm I

EXPERIMENTAL

Patients undergo external proton beam radiotherapy once daily, 5 times per week, for up to 9 weeks. Patients also receive cisplatin IV once weekly for 6 weeks during radiotherapy.

Radiation: proton beam radiation therapy; Radiation: radiation therapy treatment planning/simulation; Drug: cisplatin

Interventions

proton beam radiation therapy RADIATION

Undergo external proton beam radiation

Arm I

radiation therapy treatment planning/simulation RADIATION

Arm I

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP, Neoplatin, PDD

Arm I

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically documented carcinoma of the uterine cervix
• FIGO Stage IB to IVA
• Patients must have no distant metastases apart from positive lymph nodes by FDG PET
• Patients must have a Karnofsky Performance Status of \>= 60
• Treatment plan includes cisplatin and patient has no medical contraindications to the administration of cisplatin
• Adequate bone marrow function: WBC \>= 3000/mm\^3; platelets \>= 75,000 mm\^3
• Adequate renal function: creatinine =\< 2.0 mg/dl (urinary diversion is permitted to improve renal function)
• Patients must have bilirubin =\< 1.5 mg/dl
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• FDG PET Scan evidence of distant disease
• No prior surgery for treatment of disease other than exploratory laparotomy or biopsy will be allowed
• No previous systemic chemotherapy will be allowed
• No prior pelvic radiation therapy is permitted other than transvaginal irradiation to control bleeding will be allowed
• Women of childbearing potential who have a positive result on screening serum pregnancy test

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Proton Therapy; Cisplatin

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

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Lillie Lin

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 24, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 18, 2011
• Last Updated: April 3, 2020

Record last verified: 2016-09