Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below.

Dose level 0: 2.2 Gy X 25 fractions = 55 Gy

Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3). This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy

Boost radiation

Junzo Chino, MD

The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).

Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)

Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.

Local-regional control is defined as local control without any nodal recurrence.

Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT). Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity.

Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.

Duke University

Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3)

Dose Level 1

Dose Level 2

Dose Level 3

Boost Radiation: Dose Level 1

Boost Radiation: Dose Level 2

Boost Radiation: Dose Level 3

Boost Radiation Dose Level 0

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

No subjects were reduced to Boost Radiation Level 0

Jennifer Mewshaw, MS RN

Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).

Treatment Arm

Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).

Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=3), or 2.8 Gy x 25 fractions = 70 Gy (N=6).

Combined Treatment Arms

Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction

Boost Radiation: Dose Level 1 (60 Gy)

Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction

Boost Radiation: Dose Level 2 (65)

Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction

Boost Radiation: Dose Level 3 (70Gy)

Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)

Dose level 1 consists of a total 65Gy given in 2.6 Gy per fraction

Dose level 1 consists of a total 70Gy given in 2.8 Gy per fraction

Spots Global Cancer Trial Database for Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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