A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- intensity-modulated radiation therapy
- Conditions
- Cervical Cancer
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 106
- Locations
- 152
- Primary Endpoint
- Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Detailed Description
OBJECTIVES: * Determine the transportability of intensity modulated radiotherapy (IMRT) to a multi-institutional setting in patients with resected endometrial or cervical cancer. * Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus standard treatments. * Assess adverse events related to this regimen. * Estimate the rates of local-regional control, distant metastasis, and disease-free and overall survival. * Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma. OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer). All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years. PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
Intervention: intensity-modulated radiation therapy
Cervical Cancer: IMRT + Chemotherapy (cisplatin)
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.
Intervention: cisplatin
Cervical Cancer: IMRT + Chemotherapy (cisplatin)
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.
Intervention: intensity-modulated radiation therapy
Outcomes
Primary Outcomes
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
Time Frame: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.
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%.
Secondary Outcomes
- Rate of Distant Metastases at Five Years(From registration to five years)
- 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.)
- Rate of Local-regional Failure at Five Years(From registration to five years.)
- Rate of Overall Survival at Five Years(From randomization to five years)
- 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 Disease-free Survival at Five Years(From registration five years)