Clinical trial · Interventional

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

A Feasibility and Phase II Study of Proton Beam Radiotherapy for Patients With Cervical Cancer and FDG-PET Positive Para-aortic Lymph Nodes

NCT01019278CI-TRIAL-00044461withdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cervical Cancer	Malignant Cervical Neoplasm	CURATED_EXACT	0.92
Stage IB Cervical Cancer	Malignant Cervical Neoplasm	CURATED_BROADER	0.78
Stage IIA Cervical Cancer	Malignant Cervical Neoplasm	CURATED_BROADER	0.78
Stage IIB Cervical Cancer	Malignant Cervical Neoplasm	CURATED_BROADER	0.78
Stage III Cervical Cancer	Malignant Cervical Neoplasm	CURATED_BROADER	0.78
Stage IVA Cervical Cancer	Malignant Cervical Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
cisplatin	Drug	Cisplatin	ALIAS
proton beam radiation therapy	Radiation	—	UNRESOLVED
radiation therapy treatment planning/simulation	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Arm I
description
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.
interventionNames
1. Radiation: proton beam radiation therapy
2. Radiation: radiation therapy treatment planning/simulation
3. Drug: cisplatin

Primary outcomes (2)

measure
Feasibility
measure
Acute toxicity, as assessed by NCI CTC Version 4.0
timeFrame
Within 60-90 days following completion of proton therapy

Secondary outcomes (2)

measure

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion

* 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

Exclusion

* 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

References

Publications (0)

Data not yet available

No reference posted for this study.